Regulatory Affairs Cmc Specialist
24 ore fa
Job PurposeWe are looking for a Regulatory Affairs CMC Specialist who has consolidated experience on Chemistry, Manufacturing and Control (CMC) aspects in order to manage the preparation of dossiers for submission to regulatory authorities worldwide.Key ResponsibilitiesWriting and managing technical sections of Module 3 in collaboration with relevant departments/functionsAssessment of documentary/technical gaps associated with existing products, processes and methods (Gap Analysis)Evaluation of technical reports (Process Validation Protocols & Reports, Analytical Methods Validation, AMT, Development Reports, TT)Competence on how to translate technical reports into regulatory documents suitable for submission to the Regulatory AuthoritiesVerification (with critical vision) of Modules 3 of existing products in order to predict the potential future regulatory impact associated with those products and related variationsSupport to Change Control Management activitiesParticipation as an active member of cross-functional teams as neededRequired EducationDegree in life science or related field is requiredRequired Skills and Experience5-7 years of working experience in CMC regulatory affairsThe figure sought is a Specialist in the Regulatory CMC sector with an extremely technical cut who has previous business experience (eg manufacturing Compliance, Regulatory CMC) and/or a proven experience in the consulting sector or both of the above.The resource must have adequate skills to understand and deal with the "intelligent and targeted" writing of a section of Module 3 in order to place in it the correct information expected by Regulatory Authorities.
The resource must know the guidelines governing the CMC sector, such as GMP, ICH Q, EMA Quality guidelines, WHO guidelines and must be able to interpret these guidelines according to the product to be managed.Technical Competenciesanalytical chemistry / extractables & leachables / manufacturing environment / medical devices / stability data protocol/comparability study/ specifications /technical transfersRequired Behaviours and CompetenciesPositive thinking and behaviourEffective presentation and communication skillsSkilled in time management and able to meet deadlinesInitiatives and self-motivation abilitiesRequired LanguagesFluent in English
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